Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01438229




Trial ID
NCT01438229
Ethics application status
Date submitted
19/09/2011
Date registered
21/09/2011
Date last updated
24/05/2015

Titles & IDs
Public title
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Scientific title
Ablation-induced Renal Sympathetic Denervation Trial
Secondary ID [1] 0 0
Arsenal
Secondary ID [2] 0 0
CI-10-045-ID-HT
Universal Trial Number (UTN)
Trial acronym
EnligHTN-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

Experimental: renal artery ablation - Catheter-based RF ablation in renal artery


Treatment: Devices: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
Catheter-based RF ablation in renal artery

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events - All device or procedure related adverse events
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Office Systolic Blood Pressure Change
Timepoint [2] 0 0
Baseline to 6 months

Eligibility
Key inclusion criteria
- Office systolic blood pressure that remains =160 mmHg (=150 mmHg for patient with type
2 diabetes) despite the stable use of =3 antihypertensive medications concurrently at
maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior
to enrollment

- Age =18 and =80 years old

- Able and willing to provide written informed consent to participate in the study

- Able and willing to comply with the required follow-up schedule
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior renal artery intervention (balloon angioplasty or stenting)

- Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in
either renal artery

- Multiple main renal arteries in either kidney

- Main renal arteries <4 mm in diameter or <20 mm in length

- eGFR of <45 mL/min per 1.73 m2 using the MDRD formula

- Type 1 diabetes

- Renovascular hypertension or hypertension secondary to other renal disorders
(glomerulonephritis, polycystic kidney disease, end-stage renal failure)

- Others

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Greece
State/province [1] 0 0
Athens

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
St. Jude Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal
denervation in patients with resistant hypertension.
Trial website
https://clinicaltrials.gov/show/NCT01438229
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vasilias Papademetriou, MD
Address 0 0
First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries